EVERPATCH

Description of Event or Problem

ON AUGUST 18, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. A PATIENT WITH A HISTORY OF CHRONIC ANGLE-CLOSURE GLAUCOMA UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) ON (B)(6) 2024. THE PATIENT SUBSEQUENTLY REQUIRED AGV REVISION SURGERY ON (B)(6) 2024 FOR TUBE EXPOSURE, AT WHICH TIME THE AGV WAS COVERED WITH A CORNEAT EVERPATCH. APPROXIMATELY 4.5 MONTHS FOLLOWING IMPLANTATION OF CORNEAT EVERPATCH, THE CONJUNCTIVAL WOUND DEHISCED, AND THE CORNEAT EVERPATCH WAS PARTIALLY EXPOSED. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC. NO SURGICAL REVISION WAS PERFORMED. NO PERMANENT IMPAIRMENT, INCLUDING VISION LOSS, WAS OBSERVED DURING THE 18-MONTH POSTOPERATIVE PERIOD.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE IMPLANTED DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE CURRENT DEVICE INSTRUCTIONS FOR USE IDENTIFIES THE FOLLOWING POSSIBLE COMPLICATIONS: "DETACHMENT OF THE DEVICE FROM SURROUNDING TISSUE IN CASE OF TRAUMA OR WHEN CHRONIC INFLAMMATION IS NOT ADDRESSED"; AND "CONJUNCTIVAL RETRACTION OR WOUND DEHISCENCE, WHICH MAY LEAD TO EXPOSURE OF THE DEVICE AND COULD REQUIRE A CORRECTIVE PROCEDURE". MANUFACTURER REFERENCE#: (B)(4).